Effect of Enamel Cleaning on a Remineralizing Paste for Hypomineralizated Lesions

NCT07653373 | Not Yet Recruiting DMC

• 1 other identifier: UnCeuma
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Molar-incisor hypomineralization (MIH) is a qualitative defect of dental enamel, in which low mineral content and high protein content compromise the effectiveness of remineralizing treatments. Various agents have been used to remove proteins from hypomineralized enamel, such as sodium hypochlorite (NaOCl). Sodium hypochlorite is an antimicrobial irrigant capable of dissolving tissues. CPP-ACPF is used as a remineralizing agent for MIH lesions, it is capable of stabilizing calcium, phosphate, and fluoride ions on the tooth surface, maintaining them in an amorphous form. Therefore, the objective of this study is to evaluate the clinical performance of amorphous calcium fluoride casein phosphate phosphopeptide (CPP-ACPF) dental mousse on deproteinized hypomineralized enamel.

Conditions

Molar Incisor Hypomineralization

Keywords

molar hypomineralization; dental enamel; spectrophotometry; dental remineralization

Outcome Measures

Primary Outcomes (1)

• Mineralization of MIH lesions

  The measurements will be taken using a spectrophotometer (Vita Easyshade) to assess tooth brightness before and after treatment

  1 month

Study Arms (3)

Control Group (molars without hypomineralization)

NO INTERVENTION

Health molars without hypomineralization

CPP-ACPF in hypomineralized molars

EXPERIMENTAL

Hypomineralized molars treated with CPP-ACPF, without prior deproteinization. (Treatment will be administered once a week for 4 consecutive weeks).

Drug: CPP-ACPF

Sodium hypochlorite 5.25%/CPP-ACPF Group

EXPERIMENTAL

Hypomineralized molars treated with CPP-ACPF, with preliminary deproteinization (Treatment will be administered once a week for 4 consecutive weeks)

Drug: Sodium hypochlorite 5.25%; Drug: CPP-ACPF

Interventions

Sodium hypochlorite 5.25% DRUG

Sodium hypochlorite is a proteolytic substance that interferes with the cellular metabolism of proteins.

Also known as: NaOCL

Sodium hypochlorite 5.25%/CPP-ACPF Group

CPP-ACPF DRUG

Casein is a milk-derived protein that, during enzymatic digestion in the mouth, is converted into a casein phosphopeptide (CPP) molecule. CPP is capable of stabilizing calcium, phosphate, and fluoride ions on the tooth surface, keeping them in an amorphous form. Thus, CPP-ACPF functions as a reservoir of calcium phosphate.

Also known as: Amorphous calcium fluoride casein phosphate phosphopeptide

CPP-ACPF in hypomineralized molars; Sodium hypochlorite 5.25%/CPP-ACPF Group

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children must have at least one permanent molar without MIH, at least two permanent molars with mild MIH lesions (demarcated opacities without structural loss), with or without sensitivity, that are cream-white or yellowish in color and at least 2 mm in diameter. The teeth with lesions may or may not be on the same dental arch.

You may not qualify if:

• Children with visible bacterial biofilm, enamel malformations associated with syndromes, amelogenesis imperfecta, or fluorosis, and children who are allergic to milk proteins (casein) will not be eligible to participate in the study.

Sponsors & Collaborators

• Universidade Ceuma: lead
• Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão: collaborator

Study Sites (1)

Universidade Ceuma

São Luís, Maranhão, 65075-120, Brazil

Location

Related Publications (13)

• Sonmez H, Saat S. A Clinical Evaluation of Deproteinization and Different Cavity Designs on Resin Restoration Performance in MIH-Affected Molars: Two-Year Results. J Clin Pediatr Dent. 2017;41(5):336-342. doi: 10.17796/1053-4628-41.5.336.

  PMID: 28872993 BACKGROUND

• Mangum JE, Crombie FA, Kilpatrick N, Manton DJ, Hubbard MJ. Surface integrity governs the proteome of hypomineralized enamel. J Dent Res. 2010 Oct;89(10):1160-5. doi: 10.1177/0022034510375824. Epub 2010 Jul 22.

  PMID: 20651090 BACKGROUND

• Mahoney E, Ismail FS, Kilpatrick N, Swain M. Mechanical properties across hypomineralized/hypoplastic enamel of first permanent molar teeth. Eur J Oral Sci. 2004 Dec;112(6):497-502. doi: 10.1111/j.1600-0722.2004.00162.x.

  PMID: 15560832 BACKGROUND

• Gandhi S, Crawford P, Shellis P. The use of a 'bleach-etch-seal' deproteinization technique on MIH affected enamel. Int J Paediatr Dent. 2012 Nov;22(6):427-34. doi: 10.1111/j.1365-263X.2011.01212.x. Epub 2012 Jan 18.

  PMID: 22251382 BACKGROUND

• Bullio Fragelli CM, Jeremias F, Feltrin de Souza J, Paschoal MA, de Cassia Loiola Cordeiro R, Santos-Pinto L. Longitudinal Evaluation of the Structural Integrity of Teeth Affected by Molar Incisor Hypomineralisation. Caries Res. 2015;49(4):378-83. doi: 10.1159/000380858. Epub 2015 May 13.

  PMID: 25998233 BACKGROUND

• Fagrell TG, Dietz W, Jalevik B, Noren JG. Chemical, mechanical and morphological properties of hypomineralized enamel of permanent first molars. Acta Odontol Scand. 2010 Jul;68(4):215-22. doi: 10.3109/00016351003752395.

  PMID: 20392131 BACKGROUND

• Elhennawy K, Manton DJ, Crombie F, Zaslansky P, Radlanski RJ, Jost-Brinkmann PG, Schwendicke F. Structural, mechanical and chemical evaluation of molar-incisor hypomineralization-affected enamel: A systematic review. Arch Oral Biol. 2017 Nov;83:272-281. doi: 10.1016/j.archoralbio.2017.08.008. Epub 2017 Aug 19.

  PMID: 28843745 BACKGROUND

• Crombie FA, Cochrane NJ, Manton DJ, Palamara JE, Reynolds EC. Mineralisation of developmentally hypomineralised human enamel in vitro. Caries Res. 2013;47(3):259-63. doi: 10.1159/000346134. Epub 2013 Jan 29.

  PMID: 23363890 BACKGROUND

• Americano GC, Jacobsen PE, Soviero VM, Haubek D. A systematic review on the association between molar incisor hypomineralization and dental caries. Int J Paediatr Dent. 2017 Jan;27(1):11-21. doi: 10.1111/ipd.12233. Epub 2016 Apr 21.

  PMID: 27098755 BACKGROUND

• Amend S, Stork S, Lucker S, Seipp A, Gartner U, Frankenberger R, Kramer N. Influence of different pre-treatments on the resin infiltration depth into enamel of teeth affected by molar-incisor hypomineralization (MIH). Dent Mater. 2024 Jul;40(7):1015-1024. doi: 10.1016/j.dental.2024.05.010. Epub 2024 May 13.

  PMID: 38744567 BACKGROUND

• Altan H, Yilmaz RE. Clinical evaluation of resin infiltration treatment masking effect on hypomineralised enamel surfaces. BMC Oral Health. 2023 Jul 3;23(1):444. doi: 10.1186/s12903-023-03140-6.

  PMID: 37400849 BACKGROUND

• Olgen IC, Sonmez H, Bezgin T. Effects of different remineralization agents on MIH defects: a randomized clinical study. Clin Oral Investig. 2022 Mar;26(3):3227-3238. doi: 10.1007/s00784-021-04305-9. Epub 2021 Nov 25.

  PMID: 34821978 BACKGROUND

• Kumar A, Goyal A, Gauba K, Kapur A, Singh SK, Mehta SK. An evaluation of remineralised MIH using CPP-ACP and fluoride varnish: An in-situ and in-vitro study. Eur Arch Paediatr Dent. 2022 Feb;23(1):79-87. doi: 10.1007/s40368-021-00630-5. Epub 2021 May 31.

  PMID: 34057698 BACKGROUND

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Meire C. Ferreira, PhD

CONTACT

+5598988955888; meirecofe@hotmail.com

Nicole P. Veras, PhD

CONTACT

05598983088600; npaivaveras@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

BR (1)